Clopidogrel Before Angioplasty Cuts in Half Risk of Death - PCI-CLARITY study

Sep 14, 2005 - 2:17:00 AM

Patients undergoing PCI are routinely given clopidogrel after the procedure to help prevent complications. We found that starting treatment with clopidogrel before the procedure led to a significant reduction in the risk of cardiovascular death and ischemic complications following the angioplasty.

By Brigham and Women's Hospital (BWH), [RxPG] A new study from Brigham and Womens Hospital (BWH) finds that early use of clopidogrel, an oral antiplatelet medication, started prior to rather than at the time of angioplasty, reduces the odds of death, heart attack or stroke following the angioplasty by more than 45 percent. Results of the PCI-CLARITY study were presented by Marc S. Sabatine, MD, MPH, an associate physician in the Cardiovascular Division at BWH and an instructor in Medicine at Harvard Medical School (HMS) at the European Society of Cardiology (ESC) Congress 2005 in Stockholm, Sweden on September 3  7, 2005.

Earlier this year, Sabatine and colleagues at BWH published the results of CLARITY-TIMI 28 (Clopidogrel as Adjunctive Reperfusion Therapy  Thrombolysis in Myocardial Infarction) in the New England Journal of Medicine, demonstrating that clopidogrel helped open blocked arteries and decreased the odds of a second heart attack by 31 percent. Now, this group of researchers has found that the administration of clopidogrel before angioplasty offers profound protection against major complications.

Angioplasty, also known as percutaneous coronary intervention (PCI), is a procedure performed by cardiologists to relieve coronary narrowing. More than two million PCIs are performed each year worldwide, the majority of which involve insertion of a coronary stent to help keep the artery open. Patients undergoing PCI are routinely given clopidogrel after the procedure to help prevent complications, noted Sabatine. We found that starting treatment with clopidogrel before the procedure led to a significant reduction in the risk of cardiovascular death and ischemic complications following the angioplasty.

The PCI-CLARITY trial analyzed 1,863 patients with a recent heart attack that went on to undergo PCI. Within this group 933 had been randomized to receive clopidogrel (300 mg loading dose, then 75 mg once daily) and 930 had been randomized to receive placebo when they first presented to the hospital. Primary outcomes were death, recurrent heart attack or stroke from PCI to 30 days after randomization. After analyzing results, researchers found that clopidogrel pretreatment reduced the odds of death, recurrent heart attack or stroke by 46 percent. Pretreatment also reduced the odds of a recurrent heart attack or stroke while awaiting PCI by 38 percent. The researchers found that pretreatment was beneficial regardless of the patients age or sex or delay until the procedure. According to Christopher P. Cannon, MD the Principal Investigator of CLARITY-TIMI 28, an associate physician in the Cardiovascular Division at BWH and an associate professor of Medicine at HMS, For every 23 patients we treated with clopidogrel before PCI, we prevented one major cardiovascular event. That is an amazingly big benefit that results from one to three extra doses of clopidogrel.

The rich data from CLARITY-TIMI 28 has shown us that clopidogrel is important in the treatment of heart attacks. Now we have direct evidence that it also helps reduce odds of death associated with angioplasty and stenting procedures, said senior author BWHs Eugene Braunwald, MD, HMS Distinguished Hersey Professor of Medicine and chairman of the TIMI Study Group. I am proud that BWH continues to define the standard of care for heart attack patients around the world. I believe these results are an important contribution to how we treat patients with coronary artery disease.

Publication:
The results were published simultaneously in the Journal of the American Medical Association online on September 4, 2005 and then in print in the September 14, 2005 issue.
On the web:www.brighamandwomens.org

The CLARITY-TIMI 28 trial was supported by a grant from Sanofi-Aventis and Bristol-Myers Squibb.

Brigham and Womens Hospital
BWH is a 755-bed nonprofit teaching affiliate of Harvard Medical School and a founding member of Partners HealthCare System, an integrated health care delivery network. Internationally recognized as a leading academic health care institution, BWH is committed to excellence in patient care, medical research and the training and education of health care professionals. The hospitals preeminence in all aspects of clinical care is coupled with its strength in medical research. A leading recipient of research grants from the National Institutes of Health, BWH conducts internationally acclaimed clinical, basic and epidemiological studies. For more information about BWH, please visit: www.brighamandwomens.org.

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